An interventional study of Fibre intervention and Placebo intervention in Diet, Healthy and Systemic Inflammatory Response, sponsored by Elizabeth Simpson. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Elizabeth Simpson · Not applicable, Interventional, and Basic science
The study involves intake of dietary supplements, which are commonly found in the UK diet (not pharmacological agents) to test their effects on inflammation in the body and gut microbiome composition. Study subjects will be healthy volunteers recruited from the University and local population and will be asked to attend the laboratory on 2 occasions; before and after 4-week' supplementing the diet daily with either the dietary fibres (Pectin and Inulin) or placebo (maltodextrin). At each study visit (\~3hrs), participants will be asked to provide a stool and blood sample and will have blood pressure measured. They will also consume a glucose drink to assess how effectively the body regulates its blood glucose concentration. In the week before each study visit, participants will wear an activity and glucose monitor and record their food intake.
The overall aim of the proposed project is to unlock the effect of two structurally different dietary fibres on anti-inflammatory and cardioprotective metabolic responses via the modulation of the gut microbiome and SCFAs production.
Specific Aim 1: To deliver a wealth of molecular data, including effect sizes, on the physiological effects of two distinct fibres on the changes in the composition and function of the gut microbiome and changes in the metabolomic and physiological profile of an individual.
Specific Aim 2: To investigate the mechanisms whereby the gut microbiome modulates crucial physiological parameters such, blood glucose regulation, hunger and appetite, immune function markers in response to the anti-inflammatory effects of the gut microbiome.
30 healthy, non obese volunteers will be recruited following a successful medical screening. Between recruitment and first study visit, and in the final week of the 4-week intervention (before the second study visit), participants will be asked to wear a wrist-worn activity monitor and a subcutaneous glucose monitor (Freestyle Libre 2; 7 days), to complete a dietary record (4 days), to collect a stool sample on the day before the study visit and to fast from midnight the night before this visit.
At both study visits, participants will have weight, hip/waist circumference and blood pressure measured. They will consume 75g of glucose in 300ml of water (as an oral glucose challenge) and glucose concentration will be monitored over 2 hours via the subcutaneous monitor. They will also be asked to complete some questionnaires. After completion of the first study day, participants will be randomised to receive either the dietary fibres or placebo powder. They will be given the blinded products portioned in individual sachets, with instructions to add the contents of one sachet a day to juice, smoothies or water and to consume immediately. Study visit 2 will be scheduled at the end of the 4 week 'dosing' period.
Elizabeth Simpson is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
15g of pectin and 5g Inulin provided to healthy participants for 4 weeks.
Dietary Supplement: Fibre intervention
10g of maltodextrin provided as the control to participants for 4 weeks.
Dietary Supplement: Placebo intervention
Inulin fibre (5g) and Pectin fibre (15g) was randomly allocated to eligible participants in order to test specific effects on gut microbiome composition and metabolic markers.
Maltodextrin (10g) served as a control/ placebo to compare the effects observed with inulin and pectin.
Change in microbiome profile
Change in microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 4-week intervention period
Time frame: 4 weeks
Change in inflammatory profile
Change in circulating markers of inflammation measured by ELISAs in serum samples collected pre and post the 4-week intervention period.
Time frame: 4 weeks
Changes in short chain fatty acids (SCFAs)
Change in serum SCFAs measured by mass spectrometry pre and post the 4-week intervention period
Time frame: 4 weeks
Change in heart rate variability
change in mean heart rate variability, measured across 7 days using a wrist worn activity monitor, before and in the final week of the 4-week intervention
Time frame: 4-weeks
Change in physical activity level (PAL)
change in mean PAL, measured across 7 days using a wrist worn activity monitor, before and in the final week of the 4-week intervention
Time frame: 4-weeks
Change in step count
change in mean step count, measured across 7 days using a wrist worn activity monitor, before and in the final week of the 4-week intervention
Time frame: 4-weeks
Change in systolic blood pressure (lying to standing) pre intervention
Change in systolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at pre-intervention study visit
Time frame: 4 minutes
Change in systolic blood pressure (lying to standing) post intervention
Change in systolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at post-intervention study visit
Time frame: 4 minutes
Change in diastolic blood pressure (lying to standing) pre-intervention
Change in diastolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at pre-intervention study visit
Time frame: 4 minutes
Change in diastolic blood pressure (lying to standing) post-intervention
Change in diastolic blood pressure (measured after 3 minutes of lying down and after 1 minute of standing), at post-intervention study visit
Time frame: 4 minutes
Change in heart rate (lying to standing) pre-intervention
Change in heart rate (measured after 3 minutes of lying down and after 1 minute of standing), at pre-intervention study visit
Time frame: 4 minutes
Change in heart rate (lying to standing) post-intervention
Change in heart rate (measured after 3 minutes of lying down and after 1 minute of standing), at post-intervention study visit
Time frame: 4 minutes
Change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score
Change in 'SF36' Questionnaire aggregated 'physical' score (normalised to UK population) calculated according to standard procedures (min 0, max 100), with higher score indicating better physical wellbeing; measured pre and post intervention
Time frame: 4 weeks
Change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'mental' score
Change in 'SF36' Questionnaire aggregated 'mental' score (normalised to UK population) calculated according to standard procedures (min 0, max 100), with higher score indicating better mental wellbeing; measured pre and post intervention
Time frame: 4 weeks
Change in Pittsburgh Sleep Quality Index (PSQI)
Change in PSQI score (min score 0, max 21), measured pre and post the 4-week intervention, with higher score indicating poorer sleep quality
Time frame: 4 weeks
Plan to share: No — Data arising from the current study will be used in a fully anonymised format for the purpose of publications.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Elizabeth Simpson